Rehabilitation, Tenodesis, Stroke, Internet of ThingsNCT04463888
A Smart Home-based Exoskeleton Robot System for Stroke Patients
A study testing occupational therapy in people with Rehabilitation, Tenodesis, Stroke, Internet of Things, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rehabilitation, Tenodesis, Stroke, Internet of Things
- What is being tested?
- occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Aug 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.
Who cannot join
- not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.
- Being tested
- occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapyOther
occupational therapy targeted to goals that are relevant to the functional needs of the patient
| Study group | Role | What they receive |
|---|---|---|
| Robot training with Smart Home-based Exoskeleton Robot System | Experimental | In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks . Receives: Other: occupational therapy |
| control group | Active comparator | In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks . Receives: Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Measured: baseline, 4 weeks, 16 weeks and 20 weeks
Secondary outcomes (5)
Change in the result of Fugl-Meyer assessment for UE motor function
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Measured: baseline, 4 weeks, 16 weeks and 20 weeks
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance.
Measured: baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Measured: baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Motor Activity Log
MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
Measured: baseline, 4 weeks,16 weeks and 20 weeks
Clinical global impression scale
Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system.
Measured: post-intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start19 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rehabilitation, Tenodesis, Stroke, Internet of ThingsStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463888
- Sponsor's protocol ID
- B-BR-107-084
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuo LC, Yang KC, Lin YC, Lin YC, Yeh CH, Su FC, Hsu HY. Internet of Things (IoT) Enables Robot-Assisted Therapy as a Home Program for Training Upper Limb Functions in Chronic Stroke: A Randomized Control Crossover Study. Arch Phys Med Rehabil. 2023 Mar;104(3):363-371. doi: 10.1016/j.apmr.2022.08.976. Epub 2022 Sep 16.
PubMed 36122608
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients
- ClinicalTrials.gov ID
- NCT04463888
- Acronym / sponsor ID
- B-BR-107-084
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot training with Smart Home-based Exoskeleton Robot System | Experimental | Other: occupational therapyIn addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks . |
| control group | Active comparator | Other: occupational therapyIn addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks . |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.
Key exclusion criteria (1 listed)
- not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapyoccupational therapy targeted to goals that are relevant to the functional needs of the patient | Other | Robot training with Smart Home-based Exoskeleton Robot System, control group |
Primary outcome
Change in the result of Box and blocks test
Time frame: baseline, 4 weeks, 16 weeks and 20 weeks
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
5 secondary outcomes
Change in the result of Fugl-Meyer assessment for UE motor function
Time frame: baseline, 4 weeks, 16 weeks and 20 weeks
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, 4 weeks,16 weeks and 20 weeks
Change in the result of Motor Activity Log
Time frame: baseline, 4 weeks,16 weeks and 20 weeks
Clinical global impression scale
Time frame: post-intervention (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 36122608Kuo LC, Yang KC, Lin YC, Lin YC, Yeh CH, Su FC, Hsu HY. Internet of Things (IoT) Enables Robot-Assisted Therapy as a Home Program for Training Upper Limb Functions in Chronic Stroke: A Randomized Control Crossover Study. Arch Phys Med Rehabil. 2023 Mar;104(3):363-371. doi: 10.1016/j.apmr.2022.08.976. Epub 2022 Sep 16.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy in people with Rehabilitation, Tenodesis, Stroke, Internet of Things, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Box and blocks test (time frame: baseline, 4 weeks, 16 weeks and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.